减重版司美格鲁肽“上新”，更高剂量Wegovy已在美国获批

21世纪经济报道03-23

诺和诺德近日宣布，美国食品药品监督管理局（FDA）已批准Wegovy® HD（每周一次司美格鲁肽注射液7.2 mg），用于降低过多体重并长期维持减重效果。FDA此前已向Wegovy® HD授予“局长国家优先审批券”（CNPV），从而加快了其审批进程，并凸显其在应对关键患者需求及美国国家健康优先事项方面的潜力。　　该加速批准基于STEP UP试验项目研究结果。在STEP UP试验中，每周注射一次司...

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HD（每周一次司美格鲁肽注射液7.2 mg），用于降低过多体重并长期维持减重效果。FDA此前已向Wegovy® HD授予“局长国家优先审批券”（CNPV），从而加快了其审批进程，并凸显其在应对关键患者需求及美国国家健康优先事项方面的潜力。　　该加速批准基于STEP UP试验项目研究结果。在STEP UP试验中，每周注射一次司美格鲁肽7.2 mg在肥胖症参与者中展示出20.7%的平均体重降幅，约1/3的参与者实现了25%或以上的体重降幅。在STEP UP 2型糖尿病（T2D）试验中，针对患有2型糖尿病的肥胖症参与者，司美格鲁肽7.2 mg展示出14.1%的平均体重降幅。在两项试验中，司美格鲁肽7.2 mg再次验证了其广为人知的安全性和耐受性特征，与既往司美格鲁肽用于体重管理的研究结果相当。　　诺和诺德全球总裁兼首席执行官杜麦克（Mike Doustdar）表示：“自2021年上市以来，Wegovy®已经改变了众多肥胖症患者的生活，帮助他们实现了具有临床意义的体重降幅，并获得了重要的心血管代谢获益，其中包括前所未有的心血管风险降低获益。今年早些时候，我们上市了Wegovy®片剂，随着Wegovy® HD获得加速批准，我们为司美格鲁肽注射液产品线引入了新的选择，可带来约21%的更大体重降幅。在诺和诺德，我们始终致力于提供创新治疗方案，支持肥胖人群实现更健康的生活。我们期待Wegovy® HD的上市，帮助更多人实现其体重与健康目标。”　　诺和诺德期待在2026年4月于美国上市Wegovy® HD单剂量注射笔。　　Wegovy® 7.2 mg已在欧盟和英国获批用于成人肥胖症治疗。诺和诺德预计，欧盟和英国将在2026年下半年就司美格鲁肽7.2 mg单剂量注射笔作出审批决定。 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